alka-seltzer plus severe cold night powerfast fizz

Generic: aspirin, doxylamine succinate, dextromethorphan hydrobromide, phenylephrine bitartrate

Labeler: bayer healthcare llc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name alka-seltzer plus severe cold night powerfast fizz
Generic Name aspirin, doxylamine succinate, dextromethorphan hydrobromide, phenylephrine bitartrate
Labeler bayer healthcare llc.
Dosage Form TABLET, EFFERVESCENT
Routes
ORAL
Active Ingredients

aspirin 325 mg/1, dextromethorphan hydrobromide 10 mg/1, doxylamine succinate 6.25 mg/1, phenylephrine bitartrate 7.8 mg/1

Manufacturer
Bayer HealthCare LLC.

Identifiers & Regulatory

Product NDC 0280-0068
Product ID 0280-0068_47e325dd-448e-6435-e063-6294a90ab200
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2021-07-12

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc] platelet aggregation inhibitor [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]
Physiologic Effect
decreased prostaglandin production [pe] decreased platelet aggregation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02800068
Hyphenated Format 0280-0068

Supplemental Identifiers

RxCUI
2565491
UPC
0016500594598
UNII
R16CO5Y76E 9D2RTI9KYH V9BI9B5YI2 27O3Q5ML57
NUI
N0000000160 N0000008836 M0001335 N0000175722 N0000175578 N0000008832

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name alka-seltzer plus severe cold night powerfast fizz (source: ndc)
Generic Name aspirin, doxylamine succinate, dextromethorphan hydrobromide, phenylephrine bitartrate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 6.25 mg/1
  • 7.8 mg/1
source: ndc
Packaging
  • 10 POUCH in 1 CARTON (0280-0068-01) / 2 TABLET, EFFERVESCENT in 1 POUCH
source: ndc

Packages (1)

0280-0068-01 10 POUCH in 1 CARTON (0280-0068-01) / 2 TABLET, EFFERVESCENT in 1 POUCH

Ingredients (4)

aspirin (325 mg/1) dextromethorphan hydrobromide (10 mg/1) doxylamine succinate (6.25 mg/1) phenylephrine bitartrate (7.8 mg/1)

Linked Drug Pages (1)

Alka-Seltzer Plus Severe Cold Night PowerFast Fizz ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47e325dd-448e-6435-e063-6294a90ab200", "openfda": {"nui": ["N0000000160", "N0000008836", "M0001335", "N0000175722", "N0000175578", "N0000008832"], "upc": ["0016500594598"], "unii": ["R16CO5Y76E", "9D2RTI9KYH", "V9BI9B5YI2", "27O3Q5ML57"], "rxcui": ["2565491"], "spl_set_id": ["c1fae6c7-bbac-1320-e053-2a95a90aac5a"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_pe": ["Decreased Prostaglandin Production [PE]", "Decreased Platelet Aggregation [PE]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]", "Platelet Aggregation Inhibitor [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Bayer HealthCare LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CARTON (0280-0068-01)  / 2 TABLET, EFFERVESCENT in 1 POUCH", "package_ndc": "0280-0068-01", "marketing_start_date": "20210712"}], "brand_name": "Alka-Seltzer Plus Severe Cold Night PowerFast Fizz", "product_id": "0280-0068_47e325dd-448e-6435-e063-6294a90ab200", "dosage_form": "TABLET, EFFERVESCENT", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Antihistamine [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Platelet Aggregation [PE]", "Decreased Prostaglandin Production [PE]", "Histamine Receptor Antagonists [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "Platelet Aggregation Inhibitor [EPC]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0280-0068", "generic_name": "aspirin, doxylamine succinate, dextromethorphan hydrobromide, phenylephrine bitartrate", "labeler_name": "Bayer HealthCare LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Alka-Seltzer Plus Severe Cold Night PowerFast Fizz", "active_ingredients": [{"name": "ASPIRIN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/1"}, {"name": "PHENYLEPHRINE BITARTRATE", "strength": "7.8 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210712", "listing_expiration_date": "20271231"}